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A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas

Phase 1
18 Years
Not Enrolling
Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas


- Determine the maximum tolerated dose of UCN-01 in combination with prednisone in
patients with refractory solid tumors or lymphomas.

- Determine the toxic effects of this regimen in these patients.

- Assess the pharmacokinetics of this regimen in these patients.

- Assess any tumor response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of UCN-01.

Patients receive oral prednisone daily on days 1-5 and UCN-01 IV over 36-72 hours on days
3-5. Courses repeat every 28 days for up to 2 years in the absence of disease progression or
unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the
recommended phase II dose.

Patients are followed every 3-12 months for 5 years.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study within 18

Inclusion Criteria


- Histologically confirmed solid tumor or lymphoma

- Progressive disease after standard therapy

- No other therapy is likely to improve survival

- Prostate cancer patients must have progressed through hormonal therapy with
gonadotropin-releasing hormone (GnRH) agonists and withdrawal of testosterone
receptor antagonists

- Patients must continue on GnRH agonist during study (if orchiectomy has not been
performed) and have castrate testosterone levels

- Brain metastases allowed if treated and the patient has been stable off anti-seizure
medication or steroids for > 6 months

- No local complications from disease requiring urgent therapy (i.e., hydronephrosis,
spinal cord compression, or severe pain requiring improved pain management)



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 3 months


- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 100,000/mm^3

- 12-hour fasting glucose no greater than 110 mg/dL OR

- 12-hour fasting glucose no greater than 140 mg/dL with hemoglobin A1C no greater than
6.5 mg/dL


- PT/PTT no greater than 1.5 times upper limit of normal (ULN)

- Bilirubin no greater than 1.5 times ULN (unless Gilbert's syndrome present)

- AST/ALT no greater than 2.5 times ULN


- Creatinine clearance greater than 60 mL/min OR

- Creatinine no greater than 1.5 mg/dL


- No symptomatic congestive heart failure

- No unstable angina pectoris


- No interstitial lung disease within the past year

- No requirement for oxygen therapy for hypoxia in the past 6 months


- No diagnosis of duodenal or gastric ulcer

- No severe gastritis within the past 6 months


- HIV negative

- No prior allergic reactions to other indolocarbazoles

- No diabetes or hyperglycemia within the past year that required a diabetic diet, oral
hypoglycemics, or insulin

- No other uncontrolled illness

- No active infection

- No seizure disorder

- No psychiatric illness that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study


Biologic therapy

- Not specified


- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and

- No prior UCN-01

Endocrine therapy

- See Disease Characteristics

- No other concurrent oral or IV steroids


- At least 4 weeks since prior radiotherapy and recovered


- See Disease Characteristics

- At least 21 days since prior major surgery


- See Disease Characteristics

- At least 4 weeks since prior investigational agents

- No other concurrent anticancer therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Giovanni Melillo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute - Frederick


United States: Federal Government

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • intraocular lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent mantle cell lymphoma
  • unspecified adult solid tumor, protocol specific
  • recurrent adult Burkitt lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Neoplasms



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
NCI - Center for Cancer Research Bethesda, Maryland  20892
Frederick Cancer Research and Development Center Frederick, Maryland  21702-1201